Ozurdex

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Pharmacokinetics

Plasma concentrations were
obtained from 21 patients with macular edema due to branch retinal vein
occlusion (BRVO) and central retinal vein occlusion (CRVO), and 21 patients
with diabetic macular edema (DME) prior to dosing and at 4 to 5 additional post-dose
timepoints on Days 1, 7, 21, 30, 45, 60, and 90 following the administration of
the first intravitreal implant containing 0.7 mg dexamethasone. In RVO and DME
patients, the majority of plasma dexamethasone concentrations were below the
lower limit of quantitation (LLOQ = 50 pg/mL). Plasma dexamethasone
concentrations from 12% of samples were above the LLOQ, ranging from 52 pg/mL
to 102 pg/mL. Plasma dexamethasone concentration did not appear to be related
to age, body weight, or sex of patients.

Following a single injection, OZURDEX® demonstrated
the following clinical results for the percent of patients with ≥ 15
letters of improvement from baseline in best-corrected visual acuity (BCVA):

Table 4: Number (Percent) of Patients with ≥ 15
Letters Improvement from Baseline in BCVA

Study Day

Study 1

Study 2

OZURDEX®
N=201

Sham
N=202

p-value*

OZURDEX®
N=226

Sham
N=224

p-value*

Day 30

40 (20%)

15 (7%)

< 0.01

51 (23%)

17 (8%)

< 0.01

Day 60

58 (29%)

21 (10%)

< 0.01

67 (30%)

27 (12%)

< 0.01

Day 90

45 (22%)

25 (12%)

< 0.01

48 (21%)

31 (14%)

0.039

Day 180

39 (19%)

37 (18%)

0.780

53 (24%)

38 (17%)

0.087

*P-values were based on the
Pearson's chi-square test.

In each individual study and in
a pooled analysis, time to achieve ≥ 15 letters (3-line) improvement in
BCVA cumulative response rate curves were significantly faster with OZURDEX® compared to sham (p < 0.01), with OZURDEX® treated
patients achieving a 3-line improvement in BCVA earlier than sham-treated
patients.

The onset of a ≥ 15
letter (3-line) improvement in BCVA with OZURDEX® occurs
within the first two months after implantation in approximately 20-30% of
subjects. The duration of effect persists approximately one to three months
after onset of this effect.

Posterior Segment Uveitis

The efficacy of OZURDEX® was assessed in a single, multicenter, masked, randomized study of 153
patients with non-infectious uveitis affecting the posterior segment of the
eye.

After a single injection, the
percent of patients reaching a vitreous haze score of 0 (where a score of 0
represents no inflammation) was statistically significantly greater for
patients receiving OZURDEX® versus sham at week 8 (primary
time point) (47% versus 12%). The percent of patients achieving a 3-line
improvement from baseline BCVA was 43% for patients receiving OZURDEX® versus 7% for sham at week 8.

Diabetic Macular Edema

The efficacy of OZURDEX® for the treatment of diabetic macular edema was assessed in two,
multicenter, masked, randomized, sham-controlled studies. Subjects were to be
evaluated for retreatment eligibility every three months starting from Month 6
but could only receive successive treatments at least 6 months apart.
Retreatment was based on physician's discretion after examination including
Optical Coherence Tomography. Patients in the OZURDEX® arm
received an average of 4 treatments during the 36 months.

The primary endpoint was the proportion of patients with
15 or more letters improvement in BCVA from baseline at Month 39 or final visit
for subjects who exited the study at or prior to Month 36. The Month 39
extension was included to accommodate the evaluation of safety and efficacy
outcomes for subjects who received re-treatment at Month 36. Only fourteen
percent of the study patients completed the Month 39 visit (16.8% from OZURDEX® and 12.2% from Sham).

Visual acuity outcomes by lens
status (Phakic or Pseudophakic) at different visits are presented in Figure 2
and Figure 3. The occurrence of cataracts impacted visual acuity during the
study. The visual acuity improvement from baseline increases during a treatment
cycle, peaks at approximately 3 Months posttreatment and diminishes thereafter.
Patients who were pseudophakic at baseline achieved greater mean BCVA change
from baseline at the final study visit.

aPseudophakic: OZURDEX® , N=82; Sham, N=99bPhakic: OZURDEX® , N=246; Sham, N=229c14% (16.8% from OZURDEX® and 12.2% from Sham) of
patients had BCVA outcome at Month 39, for the remaining patients the data at
Month 36 or earlier was used in the analysis.

Last reviewed on RxList: 11/10/2014
This monograph has been modified to include the generic and brand name in many instances.